id.DRIVE (former COVIDRIVE) Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe

id.DRIVE (former COVIDRIVE) Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe - id.DRIVE CVE VE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031462

Enrollment

40000

Registered

2023-03-10

Start date

2023-04-05

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

U07.1

Interventions

Group 1: Patients hospitalised for severe acute respiratory infection (SARI)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals (patients) need to fulfil the following inclusion criteria: • Ever eligible for COVID-19 vaccination following the national/regional immunisation recommendations prior to hospital admission AND • Willing and able to provide informed consent, when applicable, obtained from the patient or from the patient’s Legally Acceptable Representative(s) (LAR)

Exclusion criteria

Exclusion criteria: COVID-19 hospitalisation within 3 months prior to the current admission. Hospital transfers are not considered as a prior hospitalisation. • Cannot be swabbed due to severe septum deviation, obstruction, or other conditions that contra-indicate swabbing • Received last vaccine dose with other than EMA-approved COVID-19 vaccine brand (EMA approval status at time of hospitalisation)

Design outcomes

Primary

Measure	Time frame
Co-primary objectives: 1. To estimate brand-specific COVID-19 vaccine effectiveness (CVE) against hospitalisation due to laboratory-confirmed SARS-CoV-2 in severe acute respiratory infection (SARI) patients who have been vaccinated with at least 1 COVID-19 vaccine dose, compared to unvaccinated patients. 2. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who completed a primary series vaccination, compared to unvaccinated patients. 3. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed a primary series with any COVID-19 vaccine and have received at least one additional COVID-19 vaccine dose (1), compared to, ? unvaccinated patients ? patients who previously received a primary series vaccination with any COVID-19 vaccine but who did not receive the last additional dose of interest (2) 4. [Only to support the interpretation of objective 3 (3)]: To estimate CVE across brands against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed at least a primary series with any COVID-19 vaccine but who did not receive the last additional dose of interest (2), compared to unvaccinated patients. Footnotes: (1) Throughout the protocol, additional dose refers to booster doses (1st, 2nd, 3rd...). COVID-19 vaccine dose will be classified as primary (P) or additional dose (N) by expert consensus. (2) Patients who did not receive the last additional dose received one dose less (P+N-1) compared to the patients who received one additional dose of the brand of interest (P+N). (3) The SARI patients used for the supporting objective are exactly the same patients as the ones used for the comparator groups of the supported objective. Note: Protocol amendment 7.0 came into effect from September 2025.	—

Measure

Time frame

Co-primary objectives: 1. To estimate brand-specific COVID-19 vaccine effectiveness (CVE) against hospitalisation due to laboratory-confirmed SARS-CoV-2 in severe acute respiratory infection (SARI) patients who have been vaccinated with at least 1 COVID-19 vaccine dose, compared to unvaccinated patients. 2. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who completed a primary series vaccination, compared to unvaccinated patients. 3. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed a primary series with any COVID-19 vaccine and have received at least one additional COVID-19 vaccine dose (1), compared to, ? unvaccinated patients ? patients who previously received a primary series vaccination with any COVID-19 vaccine but who did not receive the last additional dose of interest (2) 4. [Only to support the interpretation of objective 3 (3)]: To estimate CVE across brands against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed at least a primary series with any COVID-19 vaccine but who did not receive the last additional dose of interest (2), compared to unvaccinated patients. Footnotes: (1) Throughout the protocol, additional dose refers to booster doses (1st, 2nd, 3rd...). COVID-19 vaccine dose will be classified as primary (P) or additional dose (N) by expert consensus. (2) Patients who did not receive the last additional dose received one dose less (P+N-1) compared to the patients who received one additional dose of the brand of interest (P+N). (3) The SARI patients used for the supporting objective are exactly the same patients as the ones used for the comparator groups of the supported objective. Note: Protocol amendment 7.0 came into effect from September 2025.

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Secondary

Measure	Time frame
Secondary objectives: All secondary objectives are stratifications to the co-primary objectives. 1. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who have been vaccinated with at least 1 COVID-19 vaccine dose, compared to unvaccinated patients, ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between COVID-19 vaccine doses. 2. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who have completed a primary series vaccination, compared to unvaccinated patients, ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between COVID-19 vaccine doses. 3. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed a primary series with any COVID-19 vaccine and have received at least one additional COVID-19 vaccine dose (1), compared to (A) unvaccinated patients and to (B) patients who previously completed a primary series with any COVID-19 vaccine but who did not receive the last additional dose of interest (2), ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between last two COVID-19 vaccine doses. ? by number or type(s) (4) of the COVID-19 vaccine doses given prior to the last dose. 4. [Only to support the interpretation of secondary objective 3 (3)]: To estimate CVE across brands against hospitalisation due to laboratory-confirmed SARS-CoV-2 in	—

Measure

Time frame

Secondary objectives: All secondary objectives are stratifications to the co-primary objectives. 1. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who have been vaccinated with at least 1 COVID-19 vaccine dose, compared to unvaccinated patients, ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between COVID-19 vaccine doses. 2. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who have completed a primary series vaccination, compared to unvaccinated patients, ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between COVID-19 vaccine doses. 3. To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who previously completed a primary series with any COVID-19 vaccine and have received at least one additional COVID-19 vaccine dose (1), compared to (A) unvaccinated patients and to (B) patients who previously completed a primary series with any COVID-19 vaccine but who did not receive the last additional dose of interest (2), ? by SARS-CoV-2 genetic variants. ? within populations of special interest (e.g. specific age groups, specific immunocompromised or chronic conditions, pregnant women). ? by time since last COVID-19 vaccine dose. ? by time between last two COVID-19 vaccine doses. ? by number or type(s) (4) of the COVID-19 vaccine doses given prior to the last dose. 4. [Only to support the interpretation of secondary objective 3 (3)]: To estimate CVE across brands against hospitalisation due to laboratory-confirmed SARS-CoV-2 in

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Countries

Germany, Italy, Spain, United Kingdom

Contacts

Public ContactKaatje Bollaerts

P95 Clinical & Epidemiology Services

kaatje.bollaerts@p-95.com+32 16 23 50 13

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026